The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section

Hypotension Clinical Trial

Official title:

The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03931863
• Other study ID #: 124/17-04-2019
• Status: Recruiting
• Phase: Phase 3
• Start date: May 22, 2019
• Est. completion date: May 2022

Study information

• Verified date: January 2021
• Source: Aretaieion University Hospital
• Contact: Stavroula Karachanidi
• Phone: +306970253686
• Email: skarahanidi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the administration of two different doses of ondansetron to placebo to prevent hypotension and bradycardia following spinal anaesthesia. Apart from haemodynamic parameters (blood pressure and heart rate),characters of the spinal blockage (time of onset and regression) will be recorded too.

Description:

The day before surgery the procedure will be explained to the patient and the written consent will be obtained. In the operating room, intraoperative monitoring will include electrocardiography (ECG), noninvasive blood pressure, oxygen saturation by pulse oximetry (SpO2) and heart rate (HR). Two peripheral intravenous catheters wil be placed for fluid replacement and administration of drugs.

Participants will be randomly assigned to one of the following groups:

Group A: Women will receive 4 milligrams (mg) of ondansetron diluted in 100 milliliters (ml) of normal saline 0.9 percent 10 minutes before spinal anaesthesia

Group B:Women will receive 8 mg of ondansetron diluted in 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia

Group C:Women will receive 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia

Subsequently, after receiving 500ml of colloid solution, spinal anesthesia will be performed at level L3-L4 or L4-L5 in the vertebral space with 1.6ml of 0.75 percent ropivacaine and 15mcg of fentanyl, using a 27-gauge pencil point spinal needle with patients in a left lateral position. After subarachnoid infusion, participants will be placed supine with left uterine displacement and anesthetic and motor blockage will be evaluated every one minute until anesthetic blockage reaches the level of T4 neurotome and the motor block becomes complete (Bromage grade 3). This time will be called Time to max effect (Tmax).

Hypotension, defined as systolic blood pressure below 100 millimeters of Mercury (mmHg), will be treated using 5mg ephedrine if the heart rate is less than 100 beats per minute or with 20mcg of phenylephrine if the heart rate is greater than 100 beats per minute. Bradycardia, defined as a fall in heart rate below 60 beats per minute will be treated with atropine (0.6mg).

Immediately after the delivery of the neonate, all women will receive a solution of oxytocin (20 units) intravenously. Half an hour before the end of the procedure they will receive an additional 1g of paracetamol and 75mg of diclofenac.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Physical status according to American Society of Anesthesiologists (ASA) I-II

• Singleton pregnant women in full term pregnancy

• Patients scheduled for cesarean section

• Height 158cm-170cm

Exclusion Criteria:

• patient's own refusal

• contraindications to spinal anesthesia (coagulation disorders, inflammation at the puncture site, allergy to local anesthetics)

• ondansetron allergy

• body mass index> 33kg / m^2

• height <158cm, or> 170cm

• hypertensive disorders of pregnancy

• cardiovascular disease

• receiving selective serotonin reuptake inhibitors (SSRI's) or treatment for migraine

• placenta previa.

Related Conditions & MeSH terms

• Hypotension

Intervention

Drug:
• Ondansetron 4mg
Intravenous administration of ondansetron 4mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
• Ondansetron 8mg
Intravenous administration of ondansetron 8mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
• 100ml normal saline 0.9 percent
Intravenous administration of 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.

Locations

Country	Name	City	State
Greece	Aretaieio Hospital, University of Athens	Athens	Attiki

Sponsors (2)

Lead Sponsor	Collaborator
Aretaieion University Hospital	University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Systolic Blood Pressure during cesarean section	every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery	60 minutes
Primary	Change from Baseline Heart Rate	every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery	60 minutes
Secondary	Sensory blockade	Time for onset of sensory block at T4	20 minutes
Secondary	Motor blockade	Time to Bromage 2 and to Bromage 3	20 minutes
Secondary	Sensory regression	Time to two segment regression	120 minutes
Secondary	Motor block regression	Time to Bromage 1 and Bromage 0	120 minutes
Secondary	Time to maximum effect (Tmax)	Time when the motor blockade is complete and sensory blockade is in at the level of T4 dermatome	20 minutes
Secondary	Time to minimum effect (Tmin)	Time to two segment regression of the sensory block (T6) and for motor block regression to Bromage1 and Bromage 0	120 minutes
Secondary	Nausea	Scale for nausea (0:no nausea 10:worst possible nausea)	0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Secondary	Vomiting	Number of vomits	0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Secondary	Shivering	Yes:shiver No:no shiver	0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Secondary	Total ephedrine consumption	Total ephedrine consumption intraoperatively	60 minutes
Secondary	Total phenylephrine consumption	Total phenylephrine consumption intraoperatively	60 minutes
Secondary	Total atropine consumption	Total atropine consumption intraoperatively	60 minutes
Secondary	Neonate Apgar score	Apgar score in the 1st and 5th minute after delivery of the neonate	5 minutes
Secondary	Umbilical cord ph	Umbilical cord ph after delivery	15 minutes
Secondary	Need for administration of antiemetic agent	Need for administration of antiemetic agent intraoperatively	90 minutes